Single-center Transversal Observational Study on the Evaluation of S100B Changes in Subjects Attending the Emergency Department With Head Trauma

The aim of the study is to evaluate blood levels of the calcium-binding protein S100B as a diagnostic biomarker for the management of patients with suspected traumatic brain injury. With a sensitivity of 97% and a negative predictive value greater than 99%, S100B measurement can predict the absence of brain injury, supporting risk stratification and the safe discharge of low-risk patients. This, in turn, may reduce the need for imaging studies and shorten emergency department stays. The management of patients enrolled in the study will be identical to that of non-enrolled patients. The only difference is that patients in the study will undergo a blood draw, whereas in routine practice blood tests are not mandatory (although they are often performed).

NCT Number	NCT07036146
Lead Sponsor	IRCCS San Raffaele
Conditions	Head Trauma
Enrollment	1,000 participants
Start Date	2025-09-01
Primary Completion	2027-07-01 (estimated)
Study Completion	2027-12-31 (estimated)
Updated on ClinicalTrials.gov	2025-09-24